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Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234 recall

Philips Ultrasound, LLC recalled Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234 on September 30, 2026 because of due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causing inaccurate blood flow velocity measurements and misdiagnosis. It was sold nationwide.

Why it was recalled

Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causing inaccurate blood flow velocity measurements and misdiagnosis.

What's recalled

Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234

Quantity: 219 units

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Philips Ultrasound, LLC, Bothell, WA
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
Worldwide - US Nationwide distribution in the states of AL, CA, CT, FL, GA, KS, MD, MN, NJ, NY, OH, PA, SC, TN, TX, VA, WA, WI and the countries of Austria, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lithuania, Netherlands, Norway, Philippines, Poland, Romania, Slovenia, South Korea,…
Status
Ongoing
Recall number
Z-3249-2026
Source
U.S. Food and Drug Administration

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